Quality of informed consent in cancer clinical trials: a cross-sectional survey
Quality of informed consent in cancer clinical trials: a cross-sectional survey
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DOI：
10.1016/s0140-6736(01)06805-2
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发表时间：
2001-11-24
期刊：
影响因子：
168.9
通讯作者：
Weeks, JC
中科院分区：
文献类型：
--
作者：
Joffe, S;Cook, EF;Weeks, JC
背景研究者在临床试验中招募受试者之前必须获得知情同意。我们希望测量癌症治疗临床试验参与者的理解质量，以确定增加理解的相关性，并评估提供者对临床研究的信念。我们还寻求证据的治疗误解的参与者和providers.Methods我们发送了一个标准的问卷调查，287名成年癌症患者最近参加了一项临床试验，在三个附属institutions之一，并调查了供应商谁获得每个病人的consent.Findings 207 287（72%）患者回答。90%（186）的受访者对知情同意过程感到满意，大多数人认为自己知情。然而，许多人没有认识到非标准治疗（74%），参与风险增加的可能性（63%），治疗的未经证实的性质（70%），对自身利益的不确定性（29%），或者试验主要是为了使未来的患者受益（25%）。在多变量分析中，知识的增加与大学教育、在家只说英语、使用美国国家癌症研究所的知情同意书模板、在最初讨论时不签署知情同意书、护士在场以及仔细阅读知情同意书有关。只有28的61供应商（46%）认识到，临床试验的主要原因是有利于未来patient.Interpretation癌症临床试验的误解是试验参与者之间频繁，和医生/研究人员可能会分享这些误解的一些。需要努力教育提供者和参与者关于临床试验的基本目标。
Background Investigators have to obtain informed consent before enrolling participants in clinical trials. We wanted to measure the quality of understanding among participants in clinical trials of cancer therapies, to identify correlates of increased understanding, and to assess providers' beliefs about clinical research. We also sought evidence of therapeutic misconceptions in participants and providers.Methods We sent a standard questionnaire to 287 adult patients with cancer who had recently enrolled in a clinical trial at one of three affiliated institutions, and surveyed the provider who obtained each patient's consent.Findings 207 of 287 (72%) patients responded. 90% (186) of these respondents were satisfied with the informed consent process and most considered themselves to be well informed. Nevertheless, many did not recognise nonstandard treatment (74%), the potential for incremental risk from participation (63%), the unproven nature of the treatment (70%), the uncertainty of benefits to self (29%), or that trials are done mainly to benefit future patients (25%). In multivariate analysis, increased knowledge was associated with college education, speaking only English at home, use of the US National Cancer Institute consent form template, not signing the consent form at initial discussion, presence of a nurse, and careful reading of the consent form. Only 28 of 61 providers (46%) recognised that the main reason for clinical trials is benefit to future patients.Interpretation Misconceptions about cancer clinical trials are frequent among trial participants, and physician/investigators might share some of these misconceptions. Efforts to educate providers and participants about the underlying goals of clinical trials are needed.